Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus

Inclusion Criteria:

• Ability to understand and comply with the protocol and provide informed consent.

• Speaks English.

• Age ≥ 18 years.

• Clinical diagnosis of discoid lupus as assessed by the PI.

• At least one active (inflamed) discoid lesion with an IGA score of ≥ 3 and with adiameter ≥ 1cm at screening and baseline. Two lesions with equal scores will benecessary if consenting to pre-and post-treatment biopsies.

• Maximum body surface area of 20%.

Exclusion Criteria:

• Unwillingness or inability to complete informed consent process or comply with thestudy protocol.

• Pregnant or breast-feeding women, or women planning to become pregnant or breastfeedduring the study.

• History of coagulopathy, pulmonary embolism or deep venous thrombosis.

• History of cutaneous squamous cell carcinoma localized to the treatment area.

• Serum creatinine > 1.5 mg/dL, or alanine aminotransferase or aspartateaminotransferase > 1.5 × upper limit of normal.

• Other dermatologic disease besides discoid lupus whose presence or treatments couldcomplicate assessments.

• Other diseases besides dermatologic disorders whose treatment could complicateassessments. Subjects with systemic lupus erythematosus are permitted as long asthey do not have unstable disease and meet all other criteria, including theexclusion criteria for systemic immunosuppressive or immunomodulating drugs (below).

• Topical treatments for discoid lupus within 2 weeks of Visit 2.

• Systemic immunosuppressive or immunomodulating drugs (e.g. oral or injectablecorticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine)other than antimalarials (hydroxychloroquine, chloroquine, quinacrine) within 4weeks or 5 half-lives of Visit 2 (whichever is longer).

• Potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5half-lives, whichever is longer, before Visit 2 (topical agents with limitedsystemic availability are permitted).

• Prior use of JAK inhibitors, systemic or topical, within the last 12 months.

• Ultraviolet (UV) therapy or tanning within 2 weeks prior to Visit 2 or during theduration of the treatment period.

• Any systemic or local infection that, in the opinion of the investigator, maycompromise the safety of the subject or complicate assessments.

• Subjects allergic to lidocaine or with a history of keloids will not be allowed toprovide an optional skin biopsy, but will be eligible for the remainder of thestudy.

• Electrocardiogram (ECG) changes on baseline screening consistent with high risk fora major adverse cardiovascular event (MACE).